Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PFO ACCESS Registry

Expanded access is currently available for this treatment.
Verified January 2015 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00583401
First received: December 21, 2007
Last updated: January 30, 2015
Last verified: January 2015
  Purpose

Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.


Condition Intervention
Patent Foramen Ovale
Stroke
Device: Device closure with the AMPLATZER PFO Occluder

Study Type: Expanded Access     What is Expanded Access?

Further study details as provided by St. Jude Medical:

Intervention Details:
    Device: Device closure with the AMPLATZER PFO Occluder
    Device closure with the AMPLATZER PFO Occluder
  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patent foramen ovale-(PFO)
  • recurrent stroke
  • failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

  • International normalized ration (INR) outside of 2-3 intracardiac thrombus (subjects may be enrolled after resolution of thrombus)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583401

Contacts
Contact: Karen Cook kcook@sjm.com

Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00583401     History of Changes
Obsolete Identifiers: NCT00557479
Other Study ID Numbers: AGA-011, G060145
Study First Received: December 21, 2007
Last Updated: January 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
PFO
stroke

Additional relevant MeSH terms:
Foramen Ovale, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial

ClinicalTrials.gov processed this record on March 03, 2015